MedPath

Vitamin D3

Generic Name
Vitamin D3
Brand Names
Adrovance, Animi-3 With Vitamin D, Citranatal B-calm Kit, Citranatal Harmony, Fosamax Plus D, Fosavance, Infuvite, Infuvite Pediatric, Mvc-fluoride, Natafort, Pregvit, Vidextra, Vantavo (previously Alendronate sodium and colecalciferol, MSD)
Drug Type
Small Molecule
Chemical Formula
C27H44O
CAS Number
67-97-0
Unique Ingredient Identifier
1C6V77QF41

Overview

Vitamin D, in general, is a secosteroid generated in the skin when 7-dehydrocholesterol located there interacts with ultraviolet irradiation - like that commonly found in sunlight . Both the endogenous form of vitamin D (that results from 7-dehydrocholesterol transformation), vitamin D3 (cholecalciferol), and the plant-derived form, vitamin D2 (ergocalciferol), are considered the main forms of vitamin d and are found in various types of food for daily intake . Structurally, ergocalciferol differs from cholecalciferol in that it possesses a double bond between C22 and C23 and has an additional methyl group at C24 . Finally, ergocalciferol is pharmacologically less potent than cholecalciferol, which makes vitamin D3 the preferred agent for medical use . Appropriate levels of vitamin D must be upheld in the body in order to maintain calcium and phosphorus levels in a healthy physiologic range to sustain a variety of metabolic functions, transcription regulation, and bone metabolism . However, studies are also ongoing to determine whether or not cholecalciferol may also play certain roles in cancer, autoimmune disorders, cardiovascular disease, and other medical conditions that may be associated with vitamin D deficiency .

Indication

Cholecalciferol use is indicated for the treatment of specific medical conditions like refractory rickets (or vitamin D resistant rickets), hypoparathyroidism, and familial hypophosphatemia . Concurrently, as one of the most commonly utilized forms of vitamin D, cholecalciferol is also very frequently used as a supplement in individuals to maintain sufficient vitamin d levels in the body or to treat vitamin D deficiency, as well as various medical conditions that can be associated directly or indirectly with vitamin d insufficiency like osteoporosis and chronic kidney disease, among others .

Associated Conditions

  • Bone Fractures
  • Calcium and Vitamin D Deficiencies
  • Deficiency of Vitamin D3
  • Deficiency, Vitamin A
  • Deficiency, Vitamin D
  • Hip Fracture
  • Hypoparathyroidism
  • Hypophosphatemia, Familial
  • Menopause
  • Osteomalacia
  • Osteoporosis
  • Postmenopausal Osteoporosis
  • Vertebral Fractures
  • Vitamin D Resistant Rickets
  • Vitamin Deficiency
  • Severe Bone Resorption
  • Spine fracture

Research Report

Published: Jul 14, 2025

A Comprehensive Monograph on Cholecalciferol (Vitamin D3): From Molecular Structure to Clinical Application

Executive Summary

Cholecalciferol, commonly known as Vitamin D3, is a fat-soluble secosteroid that functions as a critical prohormone within the human body. While historically classified as a vitamin, its endogenous synthesis in the skin upon exposure to sunlight and its subsequent multi-organ activation into a potent hormone underscore its central role in a complex endocrine system. The primary and undisputed function of the Vitamin D system is the maintenance of calcium and phosphate homeostasis, which is essential for normal bone mineralization. Consequently, Cholecalciferol is a cornerstone therapy for the prevention and treatment of a range of skeletal disorders arising from its deficiency, including rickets in children, osteomalacia in adults, and as an adjunct with calcium for osteoporosis management.

A significant body of scientific evidence has established the clinical superiority of Cholecalciferol (D3) over its plant-derived counterpart, Ergocalciferol (D2). Studies consistently demonstrate that D3 is more potent and has a longer duration of action in raising and sustaining serum concentrations of 25-hydroxyvitamin D, the key indicator of vitamin D status. This has led to a broad consensus that Cholecalciferol should be the preferred form for both supplementation and therapeutic repletion.

Continue reading the full research report

Clinical Trials

View More Clinical Trials

Sign in to access the complete clinical trial database with detailed study information.

FDA Drug Approvals

View More FDA Approvals

Sign in to access additional FDA-approved drug information with detailed regulatory data.

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Oncora Pharma, LLC
85477-606
ORAL
12.5 ug in 1 1
9/5/2025
PureTek Corporation
59088-017
ORAL
10 ug in 1 1
5/2/2025
PureTek Corporation
59088-162
ORAL
18.75 ug in 1 1
4/1/2024
Avion Pharmaceuticals, LLC
75854-315
ORAL
1000 [iU] in 1 1
1/7/2021
BonGeo Pharmaceuticals, Inc.
52796-177
ORAL
600 [iU] in 1 1
2/1/2024
PureTek Corporation
59088-108
ORAL
10 ug in 1 1
9/2/2022
Bryant Ranch Prepack
63629-1136
ORAL
400 [iU] in 1 1
12/30/2021
Mission Pharmacal Company
0178-0896
ORAL
200 [iU] in 1 1
8/13/2025
Acella Pharmaceuticals, LLC
42192-323
ORAL
400 [iU] in 1 1
9/11/2018
PureTek Corporation
59088-163
ORAL
125 ug in 1 1
1/11/2023

EMA Drug Approvals

View More EMA Approvals

Sign in to access additional EMA-approved drug information with detailed regulatory data.

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

View More HSA Approvals

Sign in to access additional HSA-approved drug information with detailed regulatory data.

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

View More NMPA Approvals

Sign in to access additional NMPA-approved drug information with detailed regulatory data.

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

View More PPB Approvals

Sign in to access additional PPB-approved drug information with detailed regulatory data.

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

View More TGA Approvals

Sign in to access additional TGA-approved drug information with detailed regulatory data.

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
Prenatal Plus
396774
Medicine
A
9/30/2022
Eagle Clinical Tresos B Professional +
489429
Medicine
A
5/21/2025
VitalBoost
485229
Medicine
A
4/4/2025
Preconception Multi for Women
476988
Medicine
A
1/29/2025
Witsbb Vitamin A D softgel for Kids (clear)
475060
Medicine
A
1/6/2025
Nature’s Way Kids Smart Vita Gummies High Strength Calcium Vitamin K2+D3
473415
Pharmacare Laboratories Pty Ltd
Medicine
A
12/17/2024
Multi Vitamin
472186
Medicine
A
12/9/2024
Kidtal®️ Liquid Calcium
468809
Medicine
A
11/15/2024
Men`s Multi
467971
Medicine
A
11/11/2024
Skin + Gut
464909
Medicine
A
10/18/2024

Health Canada Drug Approvals

View More Health Canada Approvals

Sign in to access additional Health Canada approved drug information with detailed regulatory data.

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
MEL-VITA-TAB
melaleuca of canada inc.
02139693
Tablet - Oral
133 UNIT
12/31/1996
VITA VIM WITH BETA CAROTENE-CAPLET
jamieson laboratories ltd
02143453
Tablet - Oral
400 UNIT / TAB
12/31/1995
FOR KIDS ONLY CHEWABLE MULTIVITAMINS - TAB
ksl pharmaceuticals
02195771
Tablet - Oral
400 UNIT
12/31/1996
CALTRATE 600 PLUS D - TABLET
whitehall-robins inc.
02166984
Tablet - Oral
125 UNIT
12/31/1985
CALCIUM-MAGNESIUM WITH K & ZN AND VITAMIN D3
holista health (canada) inc.
02155109
Capsule - Oral
100 UNIT
8/15/1997
CHEWABLE CALCIUM 500 MG WITH VITAMIN D 200 IU
vita health products inc
02248643
Tablet - Oral
200 UNIT
1/10/2005
CHILDREN'S CHEWABLE WITH IRON
nutricorp international
02247191
Tablet - Oral
400 UNIT
9/30/2003
GERONTAL
le naturiste j.m.b. inc.
02247038
Tablet - Oral
100 UNIT
12/8/2003
CHILDRENS CHEWAB VITAMIN W CHEL MINERALS
anabolic laboratories inc.
00526673
Tablet - Oral
400 UNIT
12/31/1981
ENRICH CORE PACK FEMALE
enrich international
02242544
Capsule - Oral
80 UNIT / CAP
N/A

CIMA AEMPS Drug Approvals

View More CIMA AEMPS Approvals

Sign in to access additional CIMA AEMPS approved drug information with detailed regulatory data.

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
VITAMINA D3 FARMASIERRA 1.000 U.I COMPRIMIDOS
Farmasierra Laboratorios S.L.
86281
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica
Commercialized
ACIDO ALENDRONICO/COLECALCIFEROL SEMANAL KERN PHARMA 70 MG/2.800 UI COMPRIMIDOS EFG
82980
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica
Not Commercialized
CIMASCAL D FORTE 1.500 MG/400 UI COMPRIMIDOS MASTICABLES
Laboratorios Farmaceuticos Logogen S.A.
62796
COMPRIMIDO MASTICABLE
Medicamento Sujeto A Prescripción Médica
Not Commercialized
VERISCAL D 1.500 MG/400 UI COMPRIMIDOS MASTICABLES
Laboratorios Farmaceuticos Valomed S.A.
62442
COMPRIMIDO MASTICABLE
Medicamento Sujeto A Prescripción Médica
Commercialized
IDEOS UNIDIA 1000 MG/880 UI GRANULADO EFERVESCENTE
032033019IP
GRANULADO EFERVESCENTE
Medicamento Sujeto A Prescripción Médica
Not Commercialized
DELTIUS 25.000 UI CAPSULAS DURAS
84441
CÁPSULA DURA
Medicamento Sujeto A Prescripción Médica
Commercialized
CALDEOS 1.000 MG/880 UI COMPRIMIDOS MASTICABLES EFG
Procare Health Iberia S.L.
81859
COMPRIMIDO MASTICABLE
Medicamento Sujeto A Prescripción Médica
Commercialized
COLECALCIFEROL ROVI 30000 UI COMPRIMIDOS RECUBIERTOS CON PELICULA
83672
COMPRIMIDO RECUBIERTO CON PELÍCULA
Medicamento Sujeto A Prescripción Médica
Commercialized
ACIDO ALENDRONICO/COLECALCIFEROL SEMANAL ACCORD 70 MG/2800 UI COMPRIMIDOS EFG
84397
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica
Not Commercialized
DEVIK 25.000 UI/2,5 ML SOLUCION ORAL
84796
SOLUCIÓN ORAL
Medicamento Sujeto A Prescripción Médica
Commercialized

Philippines FDA Drug Approvals

View More Philippines FDA Approvals

Sign in to access additional Philippines FDA approved drug information with detailed regulatory data.

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

View More Saudi SFDA Approvals

Sign in to access additional Saudi SFDA approved drug information with detailed regulatory data.

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

View More Malaysia NPRA Approvals

Sign in to access additional Malaysia NPRA approved drug information with detailed regulatory data.

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

View More UK EMC Drug Information

Sign in to access additional UK EMC drug information with detailed pharmaceutical data.

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

Help Us Improve

Your feedback helps us provide better drug information and insights.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.